Australia Antigen PositiveNCT01623778
Optimization of Antiviral Therapy of Chronic HBV Infection
An observational study of Australia Antigen Positive and Hepatitis B, run by Changhai Hospital at 1 site in China.
Trial summary
Along with the improvement of the accuracy of detection of HBV serological markers, the optimization of antiviral therapy for patients with chronic hepatitis B (CHB) infection becomes feasible. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Australia Antigen Positive, Hepatitis B, Adverse Effects
- What is being tested?
- Interferon Alfa-2a add on ADV
- How many people
- 67 participants
- Where
- 1 siteChina
- Study dates
- Jan 2009to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: cases of HBeAg-positive CHB with inadequate response to 24 weeks Peg interferon alpha-2a were enrolled.
Who may be able to join
- patients receiving Peg interferon α-2a with inadequate response at 24 weeks (HBeAg titer ≥ 100Paul Ehrlich Institute Unit (PEIU)/ml and HBV DNA ≥ 5.0 Log copies/ml or HBV DNA titer decline <1 Log copies/ml) were enrolled into this study.
Who cannot join
- no decompensated cirrhosis,
- no hepatitis C, hepatitis D or human immunodeficiency virus (HIV) co-infection,
- no hepatocellular carcinoma and other tumors or history of severe hepatitis,
- no other systems diseases, such as a history of cardiopulmonary diseases, thyroid disorders, immune system disorders, epilepsy or mental illness (such as severe depression).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observation Study of Different Optimized Therapy Method of Patients With Chronic Hepatitis B
Along with the improvement of the accuracy of detection of HBV serological markers, the optimization of antiviral therapy for patients with chronic hepatitis B (CHB) infection becomes feasible. Currently, the recommendation of optimized treatment especially interferon therapy are mainly based on retrospective studies, it still lacks prospective evidence. This study is aimed to evaluate the efficacy, safety and pharmacoeconomics benefits of 48 weeks optimized interferon therapy (switch to telbivudine or plus adefovir dipivoxil) for HBeAg positive CHB with inadequate response to 24 weeks interferon treatment.
Read the detailed description
Patients with inadequate response to interferon therapy at 24 weeks were enrolled in this study and accepted the optimized therapy (add on ADV or switch to LDT) for 48weeks. All these patients were followed for 48 weeks and the HBeAg seroconversion and HBV DNA level were observed. Safety and the economic effect of the two optimized therapy methods also were observed.
- Conditions
- Australia Antigen Positive, Hepatitis B, Adverse Effects
- Being tested
- Interferon Alfa-2a add on ADV
- Keywords
- HBeAg seroconversion, Peginterferon alfa-2a, chronic hepatitis B(CHB, Optimal therapy, Response guild treatment(RGT);
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon Alfa-2a add on ADVDrug
Also called Response guild treatment, optimized therapy, Chronic HBV infection
Interferon add on ADV for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| Add on ADV | Patients with inadequate response to interferon at 24 weeks received interferon add on ADV optimized therapy Receives: Drug: Interferon Alfa-2a add on ADV | |
| Switch to LDT | Patients with inadequate response to interferon at 24 weeks received switching to LDT therapy Receives: Drug: Interferon Alfa-2a add on ADV |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBeAg seroconversion rate
Measured: 48weeks
Secondary outcomes (1)
HBV DNA decline
Measured: 48weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startJan 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Australia Antigen PositiveStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LiangXS, Changhai Hospital
- Investigators
- Wan Mo Bin, Dr, Study director, Changhai Hospital affiliated to the Second Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623778
- Sponsor's protocol ID
- HBV2012
- Status last verified
- Jun 2012
- First submitted
- 16 Jun 2012
- Last updated
- 20 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation Study of Different Optimized Therapy Method of Patients With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT01623778
- Acronym / sponsor ID
- HBV2012
- Conditions
- Australia Antigen Positive, Hepatitis B, Adverse Effects
- Keywords
- HBeAg seroconversion, Peginterferon alfa-2a, chronic hepatitis B(CHB, Optimal therapy, Response guild treatment(RGT);
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 20 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Along with the improvement of the accuracy of detection of HBV serological markers, the optimization of antiviral therapy for patients with chronic hepatitis B (CHB) infection becomes feasible. Currently, the recommendation of optimized treatment especially interferon therapy are mainly based on retrospective studies, it still lacks prospective evidence. This study is aimed to evaluate the efficacy, safety and pharmacoeconomics benefits of 48 weeks optimized interferon therapy (switch to telbivudine or plus adefovir dipivoxil) for HBeAg positive CHB with inadequate response to 24 weeks interferon treatment.
Detailed description
Patients with inadequate response to interferon therapy at 24 weeks were enrolled in this study and accepted the optimized therapy (add on ADV or switch to LDT) for 48weeks. All these patients were followed for 48 weeks and the HBeAg seroconversion and HBV DNA level were observed. Safety and the economic effect of the two optimized therapy methods also were observed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Add on ADV | – | Drug: Interferon Alfa-2a add on ADVPatients with inadequate response to interferon at 24 weeks received interferon add on ADV optimized therapy |
| Switch to LDT | – | Drug: Interferon Alfa-2a add on ADVPatients with inadequate response to interferon at 24 weeks received switching to LDT therapy |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- cases of HBeAg-positive CHB with inadequate response to 24 weeks Peg interferon alpha-2a were enrolled.
Key inclusion criteria (1 listed)
- patients receiving Peg interferon α-2a with inadequate response at 24 weeks (HBeAg titer ≥ 100Paul Ehrlich Institute Unit (PEIU)/ml and HBV DNA ≥ 5.0 Log copies/ml or HBV DNA titer decline <1 Log copies/ml) were enrolled into this study.
Key exclusion criteria (4 listed)
- no decompensated cirrhosis,
- no hepatitis C, hepatitis D or human immunodeficiency virus (HIV) co-infection,
- no hepatocellular carcinoma and other tumors or history of severe hepatitis,
- no other systems diseases, such as a history of cardiopulmonary diseases, thyroid disorders, immune system disorders, epilepsy or mental illness (such as severe depression).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interferon Alfa-2a add on ADVAlso: Response guild treatment, optimized therapy, Chronic HBV infectionInterferon add on ADV for 48 weeks | Drug | Add on ADV, Switch to LDT |
Primary outcome
HBeAg seroconversion rate
Time frame: 48weeks
1 secondary outcome
HBV DNA decline
Time frame: 48weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wan Mo Bin, Dr study director
Changhai Hospital affiliated to the Second Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Australia Antigen Positive and Hepatitis B, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBeAg seroconversion rate (time frame: 48weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2012.